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Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

NCT03911973 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-06-07

No results posted yet for this study

Summary

This study is designed to determine the RP2D of gedatolisib in combination with talazoparib and to evaluate the efficacy of this combination in advanced HER2 negative breast cancer that is triple negative or BRCA1/2 positive (deficient).

Conditions

  • TNBC - Triple-Negative Breast Cancer

Interventions

DRUG

Gedatolisib

Gedatolisib, 150-180MG IV

DRUG

Talazoparib

.75-1.00mg

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Celcuity Inc

    collaborator INDUSTRY

  • Kari Wisinski

    lead OTHER

Principal Investigators

  • Kari Wisinski, MD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911973 on ClinicalTrials.gov